Merus N.V. (Nasdaq: MRUS) (“Merus”, “the Company”, “we”, or “our”),
a clinical-stage oncology company developing innovative,
full-length multispecific antibodies (Biclonics® and Triclonics®),
today announced the appointment of Shannon Campbell as Executive
Vice President & Chief Commercial Officer. Ms. Campbell is an
accomplished healthcare leader with demonstrated success leading
commercial businesses across a range of specialty markets,
including oncology.
“Shannon will be instrumental in advancing Merus’ mission to
become a commercial-stage company, further advancing the strategy
for our lead clinical program, zenocutuzumab for neuregulin 1
fusion cancer and developing our commercial approach for our
pipeline of innovative multispecific antibody product candidates,”
said Bill Lundberg, M.D., President, Chief Executive Officer of
Merus. “Her leadership and depth of experience in launching
products, managing partnerships, and delivering sustained
performance in highly competitive oncology markets will be a great
asset to our organization.”
Ms. Campbell will join Merus as Executive Vice President &
Chief Commercial Officer in February to lead the commercial
strategy for the most advanced clinical candidate, zenocutuzumab
(Zeno), as well as Merus’ robust pipeline of multispecific product
candidates in development. This includes petosemtamab (MCLA-158),
currently under investigation in second-line head and neck squamous
cell carcinoma; MCLA-145, under investigation for solid tumors; and
MCLA-129, under investigation for patients with lung and other
solid tumors, particularly those that do not respond to EGFR
inhibitors. Merus holds global rights to all four clinical
candidates, apart from MCLA-129, for which Merus licensed to Betta
Pharmaceuticals the exclusive right to develop and commercialize in
China.
Ms. Campbell brings over 25 years of pharmaceutical
commercialization experience and joins Merus from Novartis
Pharmaceuticals, where she led Novartis’s U.S. Oncology Solid Tumor
Franchise and was responsible for a broad portfolio of therapies in
oncology and rare diseases. Prior to Novartis, Ms. Campbell was
with Bayer HealthCare Pharmaceuticals, where she was instrumental
in helping to build, launch and lead Bayer’s U.S. Oncology
business.
“I am excited to join Merus at this pivotal time,” said Ms.
Campbell. “The Merus pipeline of clinical-stage assets has the
potential to offer meaningful benefit to patients, and I look
forward to building and leading the commercial strategy for these
programs.”
Merus also announced today that Incyte (Nasdaq: INCY) has
elected to opt-out of its ex-U.S. development of MCLA-145,
restoring full global rights to Merus. MCLA-145 is currently
enrolling a global, phase 1, open-label, single-agent clinical
trial evaluating MCLA-145 in patients with solid tumors. The trial
consists of a dose escalation phase, followed by a planned dose
expansion phase. Merus is also planning to evaluate the combination
of MCLA-145 with a PD-1 blocking antibody.
"Regaining worldwide rights to MCLA-145 opens up new
possibilities for Merus," said Dr. Lundberg. "We remain committed
to continuing the development of MCLA-145 to explore the potential
of this compound as monotherapy, as well as in combination, to
address the high unmet medical need for patients with solid tumors.
We look forward to the further progress and continued success of
our other joint projects in research and development with Incyte
under this collaboration.”
Under the terms of a 2017 Collaboration and License Agreement
(“Agreement”) between Merus and Incyte, Incyte received ex-U.S.
rights to MCLA-145. Incyte’s opt-out of ex-U.S. rights to MCLA-145
provides Merus the exclusive right to develop and commercialize
potential MCLA-145 products globally. As part of the Agreement,
Incyte will continue to support the program for a limited time
while ex-U.S. activities are transitioned to Merus, and Incyte will
also retain a right to a residual royalty of up to 4% on sales of
future commercialization of MCLA-145, if approved.
Additionally, per the Agreement, the parties will continue to
collaborate on the development and commercialization of up to ten
bispecific or monospecific antibody programs. Merus also has the
option to co-fund development of product candidates arising from
two programs. For any program for which Merus exercises its
co-development option, Merus would be responsible for 35 percent of
global development costs in exchange for a 50 percent share of U.S.
profits and losses and tiered royalties ranging from 6 to 10
percent on ex-U.S. sales by Incyte for these programs. Merus also
has the right to elect to provide up to 50 percent of detailing
activities for product candidates arising from one of these
programs in the U.S.
About Merus N.V.Merus is a clinical-stage
oncology company developing innovative full-length human bispecific
and trispecific antibody therapeutics, referred to as
Multiclonics®. Multiclonics® are manufactured using industry
standard processes and have been observed in preclinical and
clinical studies to have several of the same features of
conventional human monoclonal antibodies, such as long half-life
and low immunogenicity. For additional information, please visit
Merus’ website, http://www.merus.nl and
https://twitter.com/MerusNV.
About MCLA-145Discovered through an unbiased
functional screening of multiple immunomodulatory target
combinations, MCLA-145 is a Biclonics® T-cell agonist that binds
with high affinity and specificity to human PD-L1 and CD137 in
preclinical models. The unique immunostimulatory profile of
MCLA-145 derives from the potential to potently activate immune
effector cells in the context of the tumor microenvironment while
blocking inhibitory signals among T-cells within the same immune
cell population.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this press release that do not
relate to matters of historical fact should be considered
forward-looking statements, including without limitation, Ms.
Campbell's anticipated contribution to the Company and the Merus
leadership team; the Company’s development and commercial strategy
for Merus’ clinical-stage pipeline of antibody candidates; the
impact of the collaboration between Incyte and Merus on Merus’
finances and clinical development, whether any of the programs
under the collaboration will be successful; whether and when Merus
will receive any of the expected or potential payments under the
Incyte collaboration and the amounts of such payments to Merus; the
opportunity associated with Merus’ worldwide rights to MCLA-145;
and the treatment potential of MCLA-145, its mechanism of action,
as a monotherapy as well as in combination to address the high
unmet medical need for patients with solid tumors, and future or
planned clinical trial developments or evaluations.
These forward-looking statements are based on management’s
current expectations. These statements are neither promises nor
guarantees, but involve known and unknown risks, uncertainties and
other important factors that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements, including, but not limited to, the
following: our need for additional funding, which may not be
available and which may require us to restrict our operations or
require us to relinquish rights to our technologies or antibody
candidates; potential delays in regulatory approval, which would
impact our ability to commercialize our product candidates and
affect our ability to generate revenue; the lengthy and expensive
process of clinical drug development, which has an uncertain
outcome; the unpredictable nature of our early stage development
efforts for marketable drugs; potential delays in enrollment of
patients, which could affect the receipt of necessary regulatory
approvals; our reliance on third parties to conduct our clinical
trials and the potential for those third parties to not perform
satisfactorily; impacts of the COVID-19 pandemic; we may not
identify suitable Biclonics® or bispecific antibody candidates
under our collaborations or our collaborators may fail to perform
adequately under our collaborations; our reliance on third parties
to manufacture our product candidates, which may delay, prevent or
impair our development and commercialization efforts; protection of
our proprietary technology; our patents may be found invalid,
unenforceable, circumvented by competitors and our patent
applications may be found not to comply with the rules and
regulations of patentability; we may fail to prevail in potential
lawsuits for infringement of third-party intellectual property; and
our registered or unregistered trademarks or trade names may be
challenged, infringed, circumvented or declared generic or
determined to be infringing on other marks.
These and other important factors discussed under the caption
“Risk Factors” in our Quarterly Report on Form 10-Q for the period
ended September 30, 2021 filed with the Securities and Exchange
Commission, or SEC, on November 2, 2021, and our other reports
filed with the SEC, could cause actual results to differ materially
from those indicated by the forward-looking statements made in this
press release. Any such forward-looking statements represent
management’s estimates as of the date of this press release. While
we may elect to update such forward-looking statements at some
point in the future, we disclaim any obligation to do so, even if
subsequent events cause our views to change, except as required
under applicable law. These forward-looking statements should not
be relied upon as representing our views as of any date subsequent
to the date of this press release.
Multiclonics®, Biclonics® and Triclonics® are a registered
trademarks of Merus N.V.
Investor and Media Inquiries:
Kathleen Farren
Merus N.V.
IR/Corp Comms
617-230-4165
k.farren@merus.nl
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